6.3 Planning of changes
Our discussion the past several weeks has been about building infrastructure – “pouring footings”, as it were, for the quality management system. We’ve drawn a line in the sand by clearly stating our quality policy. We’ve declared our objectives and organized our team with exactly what our objectives are and our strategy for accomplishing them. We’ve issued marching orders to our team and orders to report back periodically on their progress toward the objectives. But, what if we determine there is a need for change to the system?
This area is particularly challenging for many organizations for a number of reasons. First, change is almost always a gradual process of a system degrading unnoticed until some negative effect is realized. This is followed by many well-intentioned people offering their ideas for improvement and “throwing darts” at a solution until something begins to work. This is rarely a planned, controlled or disciplined process and can have unintended consequences or may affect other processes. So it is nice to see this addressed directly in ISO9001:2015.
The standard requires that the organization consider:
a) the purpose of the change and its potential consequences
b) the integrity of the quality management system
c) the availability of resources
d) the allocation or reallocation of responsibilities and authorities
Starting with a) the purpose of the change – it is important to consider and decide why a change should happen in the first place, and if implemented, if it will affect other processes. This requirement strongly supports a “process focus”, which was introduced in ISO9001:2008, and which has been further emphasized in the 2015 draft.
Moving onto b) the integrity of the QMS – again, this simply supports a “process focus” wherein changes must be considered in their interaction with other processes. A change in one area must not negatively impact another area. If constructed properly, the system would consider the quality policy, the critical processes identified as well as the objectives of the processes. If gains in one area create losses in another area, this is unacceptable and an alternative must be found.
Next is c) availability of resources – WOW, I really like this one! As a “lean” practitioner, I appreciate this consideration. Too often, “improvements” add layers to a process, rather than simplify it to make it more effective and efficient. This requirement states that the organization must consider the resources required to support a change and ties it back nicely to 6.2.2 planning how to achieve the quality objectives. Nice!
And finally, d) the allocation or reallocation of responsibilities and authorities – this reinforces the tie back to 6.2.2 and requires that changes be carefully planned, assigned and executed to ensure their successful implementation.
Another problem with change, overall, is that it just plain difficult to do. A universal anecdote every organization has is a time they’ve tried to implement a good idea only to have it atrophy into a return to the “old way” of doing things, or into something worse than the original process. Change management is its own industry, because it is so challenging. So having a system for planning and implementing change in your organization is critical. The requirements listed here do a fairly good job at defining the minimum components of an effective change management system.
THIS WEEK’S HOMEWORK
Review your change management process. This does not only include your document change management system, but actual changes to your quality management system. If your current system isn’t strong enough or does not address each of the requirements, shore it up with whatever it needs.
